Cerebral Vascular Accident, Death, Heart Failure Hospitalization, Myocardial Infarction
Conditions
Brief summary
This study evaluates whether achieving 25-hydroxyvitamin D (25\[OH\] Vit D) levels (\>40 ng/mL) among myocardial infarction patients will result in a reduction of cardiovascular-related adverse events. Half of the patients will be randomized to receive standard of care and half will receive clinical management of 25\[OH\] Vit D levels.
Detailed description
Low 25\[OH\] Vit D levels have become a public epidemic with increasing recognition of its widespread insufficiency both in the United States and worldwide. Epidemiologic studies have associated low 25\[OH\] Vit D levels with coronary risk factors and adverse cardiovascular outcomes. However, randomized trials are needed to establish the relevance of 25\[OH\] Vit D status to cardiovascular health. While a few randomized trials have evaluated vitamin D supplementation, none have treated to target (i.e., individual dosing so that adequate 25\[OH\] Vit D levels are obtained), but have rather given blanket doses regardless of 25\[OH\] Vit D level.
Interventions
BIOLOGICALVitamin D3
Vitamin D3 (cholecalciferol) will be provided to participants of the study.
Sponsors
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients, both male and female, \>18 years old 2. Undergone angiography for a MI (troponin positive \[\>0.04 ng/mL\] and ACS diagnosis) within the past month 3. Receive follow-up care at an Intermountain Healthcare facility 4. Not taking or taking \<1000 IU of vitamin D daily within the last 3 months 5. Willing to provide informed consent and participate in follow-up visits
Exclusion criteria
1. Hypersensitivity to vitamin D products 2. History of previous vitamin D supplementation of \>1000 IU daily within the past 3 months (i.e., \>40% of the days during the past 3 months). 3. Systemic disease (including terminal cancer, cirrhosis, end stage COPD, etc) with a reduced (\<12 months) life expectancy 4. Hypercalcemia (calcium levels \>10.6 mg/dL) 5. Subject participation in previous investigational interventional studies within 30 days of the current study. 6. History of psychiatric illness/condition that would interfere with their ability to understand or complete the requirements of the study, a condition that in the opinion of the investigator or their designee places the subject at an unacceptable risk as a participant. 7. Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception as determined by the clinical investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Outcome of Death, Myocardial Infarction, Heart Failure Hospitalization, and Cerebral Vascular Accident | from date of randomization until the date of first documented event, up to 48 months |
Countries
United States
Outcome results
None listed